BusinessWire India
New Delhi [India], October 19: Auxein, a global innovator in orthopaedic and arthroscopy solutions, is proud to announce the successful achievement of the prestigious European Union Medical Device Regulation (EU-MDR) certification 2017 issued by DNV, Norway. Auxein has made history as the first Asia's orthopaedic implant manufacturing organization to reach this milestone for its Trauma Plating, Screws & Nailing System including Tibia Plate and Screw and Femoral Nailing System. This certification strengthens Auxein's role as a leader in delivering safe, high-quality medical devices across Europe, ensuring compliance with the latest regulatory standards.
The state-of-the-art R&D and manufacturing facility is globally recognized for adhering to the highest standards in medical device production. Certification such as CE(EU-MDR), Medical Device Single Audit Program (MDSAP), ENISO 13485, USFDA 510(k), and many, Auxein's compliance aligns us with European Union health, safety, and environmental standards.
Auxein offers a comprehensive portfolio of over 3000 orthopaedic products, designed to meet a variety of patient and clinical needs. All products are CE-certified and fully compliant with the European Medical Device Directive MDD/93/42/EEC, as amended 2007/47/EC. Additionally, a selected range of products has been US FDA 510(k) cleared, further validating the safety and efficacy of Auxein's product offerings for global markets.
EU-MDR Certification - A Step Towards a Safer, Compliant Future
Achieving EU-MDR certification is a landmark accomplishment for Auxein, ensuring that all orthopaedic implants--including joint arthroplasties, screws, plates, and trauma devices--meet the stringent safety and performance standards established by the European Union. This compliance positions Auxein as a key player in the European medical device market, enhancing product traceability, clinical evaluation, and patient safety.
Gaurav Luthra, Vice President Global Manufacturing and Regulatory Head at Auxein, stated, "Securing EU-MDR certification is a testament to our relentless dedication to providing the safest, most innovative orthopaedic solutions. This achievement, combined with our extensive global certifications, positions us to drive advancements in healthcare on a global scale."
Auxein's Ongoing Commitment to Innovation
With its globally certified R&D facility and an unparalleled range of orthopaedic products, Auxein remains at the forefront of medical technology. The company's dedication to cutting-edge research and superior manufacturing enables it to deliver solutions that meet the evolving needs of healthcare professionals worldwide.
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